Methods, apparatus and compositions are disclosed for collection and transport of biological samples for testing and/or evaluation by a clinical laboratory. In particular, the disclosure relates to the self-collection of such samples by subjects providing the samples.
Tests performed by a clinical laboratory are often classified as being “screening”, “diagnostic” or “monitoring” depending upon the target population and the intended use of the test results. Screening tests are typically performed on large asymptomatic populations for the purpose of identifying the relatively few individuals within that population who have the target disease or a precursor condition thereto. Screening tests targeting risk factors for the development of a disease, rather than the disease itself, have recently been introduced and are beginning to be deployed. Early detection is a primary goal of screening programs. It has been well documented that not only does early detection of a disease and consequent early intervention generally improve the outcome for individual subjects, but it can significantly reduce the cost of healthcare on a system basis by reducing the number of subjects who progress to an advanced and more resource consuming stage of the disease. Diagnostic tests are typically performed on individual subjects who are known or strongly suspected to have a particular disease for the purposes of confirming or refuting the presence of the disease and, if present, classifying it in terms of stage and other characteristics to assist a physician in treatment planning and subject management. Monitoring tests are primarily used to track the progression of a disease or the effectiveness of a treatment in an individual subject over time.
Even if a given test can be used for screening, diagnosis and monitoring, the differences in target populations and intended uses impose significantly different requirements on these various embodiments. In many respects screening tests are the most challenging to develop and deploy as the diseases that are generally targeted in screening programs have relatively low incidence rates in the population to be screened. Therefore large to very large numbers of individuals must be tested in a relatively short period of time in order for a screening program to have any significant impact upon public health. Screening programs generally operate under stringent resource constraints, particularly with respect to funding and the availability of medically trained personnel and, in many cases, are conducted in geographic areas that have limited transportation and communications infrastructures. Operational efficiency, logistics and cost-per-result are therefore exceptionally important in screening programs.
Due in part to shortages of the medically trained personnel who are traditionally employed to collect samples in screening programs, there has been a growing demand for methods and devices that allow the subject to “self collect” their own samples for subsequent delivery to a laboratory for testing. Samples that are generally considered to be suitable for self collection comprise bodily secretions and exudates such as sputum, saliva, urine, feces, genital tract secretions, tears and sweat that can be obtained without penetrating the skin. Screening tests have long been performed on self collected urine and fecal samples, but only relatively limited use has thus far been made of the other above identified types of self collected samples at least in part due to logistics and cost issues associated with sample collection. Other issues that have hampered the adoption of self collection include the complexity and technique dependence of many of the available sample collection devices and methods and the potential for user error during the sample collection process.
The “standards of care” that define the targeted demographics and testing frequencies for various diseases within a population are basically consistent worldwide, but the rates of compliance with these standards can vary from under 25% to over 95% depending upon a number of factors. Resource limitations are a major contributor to this lack of compliance in the countries with the lowest compliance rates, but the inconvenience or difficulty associated with requiring subjects to present themselves at a designated location for sample collection is a significant factor in noncompliance in almost all countries. Yet another consideration is that in some relatively large populations religious and/or cultural practices discourage or forbid collection of certain kinds of clinical samples by medical professionals. Self collection of the requisite samples is seen as a way of addressing these issues, especially if the subject can send the sample directly to a laboratory or other designated location via a postal service, courier service or similar means.
The ability of a subject to order a clinical test on demand and to directly receive the test results has also recently become available. In this model the subject orders the test and receives the results via the Internet or other means of electronic communication. Although a few of these on-demand subject ordered tests utilize self collected samples, most require that the subject present themselves at a clinic, laboratory or other facility for sample collection by a medical professional. For economic, privacy and other reasons there is increasing interest in transitioning the majority of these on-demand tests to the use of self collected samples.
Numerous devices and kits such as those described for the self collection of clinical samples, but none have been successful due to the high level of skill required in order to obtain an acceptable sample; the high cost per result; operational complexity and other limitations.
There is therefore a need for a low cost, easy to use means for the self collection and transport of a clinical sample that can be widely deployed and can reliably be used by a subject who has had little or no training.